Cultivation of transgenic plants for commercial use is not allowed in the Russian Federation. However, several types of genetically modified (GM) food and feed lines that have passed the procedure of state registration and control are allowed to be imported, processed, and used for food or feed production. Research on genetically engineered animals is not supported by the government. Russia recently adopted an approval procedure for release of genetically modified organisms (GMOs) into the environment, which brings the country closer to possible cultivation of GM plants. Currently, eighteen GM food lines and fourteen GM feed lines are approved and registered in Russia.

I. Introduction

Recently, the Russian Federation initiated legislative attempts to frame the policy of modernization and innovation in the field of genetic engineering. The Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020 was approved in 2012. This document acknowledges that Russia is falling behind of many other countries and demonstrates that the Russian Government is interested in promoting the further development of agricultural biotechnology.[1] The government-approved Plan of Measures for the Development of Biotechnology and Genetic Engineering[2] proposes substantial measures that should be implemented within the next two or three years in biomedicine and industrial and agricultural biotechnology.[3]

Neither the Cartagena Protocol on Biosafety, nor the Aarhus Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters have been ratified by Russia. However, after joining the WTO in 2012, Russia took some steps to develop a legislative framework for the cultivation of biotech crops and use of GMOs, including a procedure for the state registration of GMOs for release into the environment. In June 2012, the main Russian authority responsible for the state control over genetically engineered foods, Rospotrebnadzor, expressed its intention to promote a positive image of GMO products in Russian society.[4]

On November 19, 2006, the Russian Federation and the United States signed an exchange letter on agricultural biotechnology during the course of the bilateral negotiations on Russia’s Accession to the WTO. According to the letter, Russia agreed to maintain an approval and registration system for products of modern biotechnology used for cultivation, food, feed, processing, and import, which will enable the use and trade of such products within the WTO framework. The letter also provided that Russia must grant the US the opportunity to comment on issues related to biotechnology regulation and will take those comments into account.[5] After the letter was signed, some anti-GMO activists in Russia called it a lobbying mechanism that virtually guarantees the US the right to directly influence decision making in the field of consumer rights and biosafety in Russia.[6]

In 2012, Russia was among the thirteen states endorsing an International Statement on Low Level Presence (LLP) in order to avoid the disruption of global trade due to national restrictions on the import of agricultural commodities with traces of GMOs. By signing this international statement, Russia committed to continue to work collaboratively with other signatory countries to address the overarching problem of asynchronous approvals of biotech products, while trying to mitigate the impact of LLP situations in food and feed.[7]

Following instructions from the Russian President, the government entrusted responsible agencies with determining whether to ban imports of products containing GMOs into the country.[8] Russian agencies responsible for the policy in this field were expected to report to Russian Prime Minister Dmitry Medvedev by October 15, 2013.[9] Previously, products that contained Monsanto’s genetically engineered corn NK603 were banned from importation into Russia.[10]

II. Public and Scholarly Opinion

Agricultural producers and scientists generally support GMO production in Russia and advocate for pro-GMO legislation.[11] On the other hand, some environmentalists claim that the penetration of agricultural biotechnology and GMO-oriented production is dangerous for the environment, public health, and national food security. In their opinion, Russia should use its huge potential for the domestic production of organic food, which they argue has higher demand and is more environmentally friendly.[12]

Surveys indicate that Russian consumers prefer to buy GMO-free food products. According to analytical surveys of food markets, the number of people concerned with the quality of their food choices has been steadily growing. Around 80% of survey respondents who bought food in Moscow stated that they would not purchase a product if it contained GM components.[13] However, the actual purchasing behavior of the Russian population is affected by the price of products.[14]

III. Structure of Pertinent Legislation

The Russian legal framework governing the safety of GMO products and the control over their circulation on the market consists mainly of several federal laws and government resolutions that regulate agricultural biotech policy. These include the Federal Law on State Regulation in the Field of Genetic Engineering Activities (amended in 2010),[15] Federal Law on the Sanitary-Epidemiological Well-Being of the Population,[16] Federal Law on the Quality and Safety of Food Products,[17] and Federal Law on Consumer Rights Protection.[18]

In 2010, Russia entered into a Customs Union with Belarus and Kazakhstan. The Union formed the basis of the Eurasian Economic Commission, a trilateral government authority in charge of harmonizing trade tariffs. Russian trade legislation is now subordinated to norms and procedures of the Customs Union and regulations issued by the Commission.[19] The Customs Union has adopted Technical Regulations on Food Safety (TR TS 021/2011), on Food Labeling (TR TS 022/2011), and on the Safety of Grain (TR TS 015/2011).[20] These regulations came into force on July 1, 2013.

The Technical Regulation on Food Safety is a key Customs Union umbrella regulation covering standards and requirements for all food products and their processing. The Technical Regulation on Food Product Labeling is designed to establish uniform requirements for food products labeling to ensure the free movement of food products released for circulation in the territory of the Customs Union member states. The Technical Regulation on the Safety of Grain covers standards and requirements for grain and oilseeds produced and traded in the territory of the Customs Union, including imported and exported grains and oilseeds.[21] A Technical Regulation on Feed, which will address genetically engineered feed, is under consideration.[22]

In September 2013, the government approved the Resolution on the State Registration of Genetically Engineered/Modified Organisms Intended for Release into the Environment and Products Derived from the Use of Such Organisms or Containing Such Organisms (the Resolution).[23] The Resolution established a registration process for GMOs released into the environment for such purposes as the production of raw food materials and foodstuffs; feed and feed additives for animals; and breeding and growing modified plants, animals, and microorganisms for agricultural use in the territory of the Russian Federation.[24]

The Rules approved by the Resolution define the functions of different government agencies in the registration and oversight of GMOs. For example, the Federal Service for Surveillance of Consumer Rights Protection will register modified organisms used for the production of raw food materials, while modified plants and animals intended for breeding in Russia and modified agricultural microorganisms will be registered and monitored by the Federal Service for Veterinary and Phytosanitary Surveillance.[25] Consolidated registration of all GMOs and GM products will be maintained by the Ministry of Health.[26] Registration will require a positive assessment of the environmental impact of the released organisms and products conducted by the Federal Service for Surveillance in the Sphere of Environmental Management.[27] The Rules will come into effect on July 1, 2014.[28]

According to a US Department of Agriculture report, before this Resolution was adopted, Russia did not have a procedure for the release of GM plants into the environment, which amounted to a de facto ban on the cultivation of any such crop. The Resolution lifts this ban, and while it will not have any immediate effect on the cultivation of biotech crops in Russia, it creates an approval process to make cultivation of such crops possible.[29]

IV. Restrictions on Research, Production, and Marketing

A. Regulation of Research

Laboratory research on genetically engineered crops has not reached the stage of field trials. While field trials are not specifically prohibited, special permission is required from the Variety Testing Commission at the Ministry of Agriculture,[30] and some companies report that such permission is no longer granted.[31] Reportedly, research on genetically engineered animals was conducted at the Russian Academy of Agricultural Sciences. No information on the continuation of this research since 2012 is available.[32]

B. Labeling Requirements

In accordance with the Federal Law of the Russian Federation on Consumers Rights Protection, all organizations that import to, produce in, or trade food and foodstuffs with Russia must inform consumers about the presence of GM components in their products if each individual biotech element exceeds 0.9% of product composition.[33] This legal provision is in line with the Technical Regulations of the Customs Union that came into effect on July 1, 2013.[34]

Several Russian regions and producers have implemented voluntary labeling showing that their products are GMO free. However, such voluntary labeling is in some cases viewed by Russian authorities as contrary to rules of competition.[35] For example, in 2007 GMO-free labeling requirements were introduced by the Moscow City Government that allowed food producers to test their products for the absence of GMO ingredients at the city government’s laboratories and receive a special, green label issued by the City Government stating that the product “Does not Contain GMO!” Following a request from the Federal Antimonopoly Service, the Moscow City Government abolished this program.[36]

Labeling of GMOs in animal feed is not required. Information on GMOs in grain and oilseeds and their products must be included in the accompanying shipping documents.[37]

C. Responsible Agencies

There is no single unified authority competent to make decisions on matters relating to the security of growing GM crops and the use of GMOs in food and animal feed. Currently, several Russian government agencies are responsible for the development of Russian biotechnology policy and controlling the use of genetically engineered crops and foodstuffs. They include the Ministry of Agriculture, the Ministry of Healthcare, the Federal Service for Surveillance of Consumer Rights Protection, the Federal Service for Veterinary and Phytosanitary Surveillance, and some others.

The Ministry of Agriculture is the country’s leading agency in charge of regulating the veterinary and phytosanitary sphere. It is responsible for mitigating any negative effects of GMOs on agricultural animals, plants, and the environment. Starting July 1, 2014, the Ministry of Healthcare will be responsible for the maintenance of the consolidated register of all GMOs and GM products intended for release into the environment. The Federal Service for Surveillance of Consumer Rights Protection (Rospotrebnadzor) surveys and controls the turnover of GM food products. It also conducts state registration of new food products containing GMOs, including imports, and keeps a state register of GM food products authorized for sale and production in, and import into, Russia. The Federal Service for Veterinary and Phytosanitary Surveillance (VPSS) is subordinated to the Ministry of Agriculture of the Russian Federation. With regard to GMOs, it controls the safety of feed and feed additives derived from GMOs.[38]

V. Restrictions on Releasing Organisms into the Environment

GMOs designed for release into the environment and the products obtained from or containing such organisms are subject to state registration.[39] In accordance with the newly adopted Rules on State Registration of GMOs and GMO-Containing Products for Release into the Environment that will come into effect on July 1, 2014, the registering authorities will issue certificates on the state registration of GMO and GMO-containing products on the basis of an application from a legal entity. GMOs used for research work are exempt from registration if they are produced in accord with the existing sanitary norms and procedures. Similarly exempt from registration are the products obtained by the combination or processing of registered GMO-containing products if the genetic material of these products is not changed.[40]

Registration of GMOs and GMO-containing products will have no expiration date. However, in the case of a negative impact of a registered GMO product on human or animal health and/or the environment, the registration certificate may be revoked or special conditions for its use may be imposed.[41]

VI. Restrictions on GMOs in Foodstuffs

A. General Requirements

According to the Federal Law on State Regulation in the Field of Genetic Engineering,those working in the field of GMOs are responsible for the safety of the public and of the environment, accessibility of information on the safety of genetic engineering activities, certification of products containing the results of genetic engineering, state registration of GMOs intended for release into the environment, and state registration of products derived from the use of such organisms or containing such organisms.[42] The Law requires that certificates provide full details regarding the methods of obtaining the product in question and its properties. It also states that products and services developed by means of genetic engineering must meet the requirements of environmental safety, public health, and pharmacopoeia provisions.[43]

Certain types of new food products, materials, and articles manufactured and intended for sale in the territory of the Russian Federation or imported for the first time into the territory of the Russian Federation are subject to state registration.[44]A special export control procedure with regard to genetically modified microorganisms (GMMs) has been established by the government.[45] Following this procedure, the periodically updated list of GMMs and genetic elements allowed for export from Russia was approved by the President of the Russian Federation in 2007.[46] The most recent updates to the list were made in July 2013.[47]

The list of foodstuffs containing GMOs subject to sanitary and epidemiological monitoring and state registration was approved by the Decision of the Customs Union Commission on the Application of Sanitary Measures within the Customs Union.[48]

As of September 2012, Russia approved and registered eighteen GM food lines (four soybean lines, ten lines of corn, two types of potatoes, one line of rice and one line of beet) and fourteen GM feed lines (four lines of soybean and ten lines of corn).[49]

B. Risk Assessment

Food and foodstuffs derived from GM sources are subject to a safety assessment procedure, which includes a 180-day toxicity study in animals and the application of modern methods of analysis.[50] Products with properties that do not differ from counterparts obtained by traditional methods and that pass medical and biological assessments are deemed safe for human health and are authorized for sale to the public and use in the food industry without restrictions.[51]

C. Fodder for Livestock

Feed derived from GMOs is subject to compulsory state registration.[52]Plant-origin feed imports require a letter stating that the feed is biotech free. Feed may be classified as biotech free if the presence in such feed of each nonregistered biotech line does not exceed 0.5% and the presence of each registered biotech line does not exceed 0.9%. If the feed contains genetically engineered ingredients and is not declared as biotech free, the shipment must include a copy of the certificate indicating that the biotech components in the feed are registered with the Federal Service for Veterinary and Phytosanitary Surveillance. Feed registration is issued for five years with the possibility of renewal.[53]

VII. Liability Regime

In Russia, while administrative liability for violations of the requirements related to GMOs has been established, the amount of financial penalties is rather insignificant. Individuals, officials, and legal entities that do not comply with the requirements of law with respect to sanitary and epidemiological standards are punishable by a fine in the amount up to 20,000 rubles (approximately US$620) or administrative suspension of operations for up to ninety days (in the case of legal entities).[54]

The sale of products in the absence of required information or proper GMO labeling entails a warning or a fine in an amount of up to 40,000 rubles (approximately US$1,240).[55]

Violations of rules related to the transportation, sale, or release of products with GMOs are punishable by a fine in an amount of up to 300,000 rubles (approximately US$9,400). Violations that cause harm to the lives or health of people, property, or the environment, or that pose a threat of such harm, entail a larger fine in an amount of up to 600,000 rubles (approximately US$19,000), and may be accompanied by confiscation of the product in question.[56]

[8] Instruction of the Prime Minister of the Russian Federation on Enforcement of the Orders of the President of the Russian Federation Made During the Meeting on Social and Economic Development of Rostov Region (Sept. 18, 2013), http://government.ru/orders/6131 (in Russian).

[9] As of the date this report, no information on further developments regarding this issue was available.

[23] Resolution of the Russian Federation Government No. 839 on State Registration of Genetically Engineered/Modified Organisms Intended for Release into the Environment and Products Derived from the Use of Such Organisms or Containing Such Organisms, http://government.ru/docs/6128 (in Russian).

[45] Regulation of the Russian Federation Government No. 634 on Control over Microorganisms, Toxins, Equipment and Technologies in the Course of Foreign Economic Activity, SZ RF 2001, No. 37 (in Russian).

[47] Decree of the Russian Federation President No. 612 on Amendments to the List of Microorganisms, Toxins, Equipment and Technologies Subject to Export Control approved by the Decree of President of the Russian Federation No. 1087 of August 20, 2007, SZ RF 2013, No. 28 (in Russian).

[53]Administrative Regulation on the State Function of the Federal Servicefor Veterinary andPhytosanitary Surveillancefor State Registrationof Feed Produced from GMOs, approved by the Order of the Ministryof Agricultureof the RussianFederation No.466 of October 6, 2009, http://www.mcx.ru/documents/document/ v7_show/11682.285.htm (in Russian).